The University of Maryland (“the University”) adopts the University of Maryland Policy on Financial Conflicts of Interest in Federally Funded Research (“this Policy”) as required to implement and to comply with federal laws and regulatory requirements. The requirements herein originated from the U.S. Public Health Service regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94), which are implemented by multiple Federal Funding Agencies. This Policy addresses these regulations as well as associated regulations and policies established by other Federal Funding Agencies.

The purpose of this Policy is to comply with regulatory requirements and their goal of promoting objectivity in Federally Funded Research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of Research funded under federal grants, cooperative agreements and contracts will be free from bias resulting from Financial Conflicts of Interest (FCOIs).

1. "COI Administrator" means the individual appointed by the University's Vice President for Research to support the implementation of this Policy, the University’s COI/COC Policy, and the University's ICOI Policy, and to oversee the work of the Disclosure Office, COI Committee, and ICOI Committee.
2. "COI Committee" means the advisory committee appointed by the President of the University in accordance with the University’s COI/COC Policy and the Disclosure and Conflict Management Guidelines and based on the authority granted by the Maryland State Ethics Commission (SEC) regarding conflicts associated with research or development.
3. "COI Official" means the University's Vice President for Research.
4. "Disclosure(s)" means information that is required to be provided on all outside professional activities, external relationships, and/or Significant Financial Interests.
5. "Family Member(s)" means a University Employee's or a Graduate Research Assistant's (GRA’s) spouse or domestic partner, parent, child, sibling, or other close relatives as defined in the USM Policy on Employment of Members of the Same Family (Nepotism) (VII-2.10).
6. "Federally Funded Research" means any Research that is funded by U.S. federal Funding Agencies, including by the U.S. government and its agencies and any sub-units within those agencies.
7. "Financial Conflict of Interest (FCOI)" means a Significant Financial Interest that affects, or could appear to affect, the design, conduct, or reporting of Research.
8. "Funding Agency(ies)" means any domestic or foreign entity that provides monetary support for a Sponsored Project to a University Employee or to the University on behalf of a University Employee. Funding Agencies may include but are not limited to entities such as the U.S. government and its agencies; U.S. state and local entities; foreign entities including governments and institutions; non-profit organizations; associations; or companies.
9. "Graduate Research Assistant(s) (GRAs)" means a registered graduate student who is enrolled in a graduate degree program at the University and is participating in Sponsored Projects as a Graduate Assistant. For the purposes of this Policy, references to GRAs include Graduate Fellows.
10. "Institutional Responsibilities" means a University Employee's or GRA's primary duties and responsibilities at the University, as defined in their contract job duties, offer letter, or other comparable documentation.
11. "Management Plan" means a written plan provided by the University that describes how a conflict or potential conflict will be managed.
12. "Research" means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences Research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter), and product development (e.g., a diagnostic test or drug). The term includes any such activity for which Research funding is available from a Federal Funding Agency through a grant, cooperative agreement, or contract, including without limitation a Research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or Research resources award.
13. "Senior/Key Personnel" means the project director or principal investigator and any other personnel considered to be responsible for the design, conduct, or reporting of the Sponsored Project, and who are identified as Senior/Key Personnel in the Sponsored Project proposal and award.
14. "Significant Financial Interest" means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., Consulting fees or honoraria); equity interest (e.g., stocks, stock options or other ownership interests); Intellectual Property rights (e.g., patents, copyrights, and revenue from such rights); and/or positions outside of the University that involve a fiduciary role for an external entity, whether compensated or not.
15. "Sponsored Project(s)" means monetary or non-monetary support provided by a domestic or foreign entity to the University to support specific research, instruction, or other activities of University Employees and/or GRAs.
16. "Unit" means a department, center, institute, division, or non-departmentalized College or School.
17. "Unit Head" means the administrator(s) responsible for a Unit and the individual(s) to whom a University Employee reports. A Unit Head may be a Director, Department Chair, Dean, Vice President, or a similar official in a non-academic Unit.
18. "University Employee(s)" means all faculty and staff employed by the University, regardless of title, FTE, full- or part-time status, and also includes University Officials.

1. This Policy outlines the University’s implementation of all relevant federal regulations and Funding Agency policies related to FCOI, as noted in the Disclosure and Conflict Management Guidelines.
2. This Policy applies to all Federally Funded Research, and to any application for or receipt of Research funding from Federal Funding Agencies by means of a grant, cooperative agreement, contract or similar legal document.
   1. Notwithstanding anything contained herein, this Policy does not apply to any Small Business Innovation Research Program (“SBIR”) or Small Business Technology Transfer (“STTR”) Program Phase I applications, or applications that do not have FCOI requirements.
3. This Policy applies to University Employees and GRAs identified as Senior/Key Personnel on Sponsored Projects for Federally Funded Research.
4. This Policy is applied concurrently with the following policies or guidelines:
   1. The University System of Maryland (USM) Policy on Conflicts of Interest in Research or Development (III-1.11);
   2. The University of Maryland Policy on Conflict of Interest and Conflict of Commitment (II-3.10[A])(“the COI/COC Policy”);
   3. The University of Maryland Policy on Organizational Conflicts of Interest (II-3.10[F]);
   4. The University of Maryland Policy on Institutional Conflicts of Interest (X-14.00[A]); and
   5. The University’s Disclosure and Conflict Management Guidelines.
5. Applicability of this Policy is subject to change per federal laws and regulations and Funding Agency guidance for Sponsored Projects. In cases where this Policy is found to conflict with federal laws and regulations, the federal laws and regulations will supersede this Policy.

1. University Employees and GRAs working on a Sponsored Project are required to submit a Disclosure in accordance with the COI/COC Policy. Disclosures will be reviewed for potential FCOIs and potential COIs/COCs at the same time.
2. Disclosures must be updated when there is a change to an item on the Disclosure, prior to acquiring a new Significant Financial Interest, and at least annually.
3. When submitting a Disclosure, University Employees and GRAs are not required to report reimbursed or sponsored travel (domestic or foreign) paid for by:
   1. The University of Maryland;
   2. U.S. federal, state, or local governmental agencies;
   3. U.S. institutions of higher education as defined at 20 U.S.C. 1001(a);
   4. U.S. research institutes affiliated with Institutions of higher education; and/or
   5. U.S. academic teaching hospitals and medical centers.
4. When required by the Federal Funding Agency, mandatory training for researchers will be provided. The training will include information on this Policy, relevant requirements and responsibilities related to disclosing Significant Financial Interests, and other topics as specified by the Funding Agency.

1. Disclosures of Significant Financial Interests will be reviewed in alignment with this Policy and the Disclosure and Conflict Management Guidelines, and a determination will be made prior to the University’s expenditure of any funds.
2. Disclosures will be reviewed by the COI Committee, as established in the COI/COC Policy, or by the COI Committee Chair and the Disclosure Office acting on behalf of the Committee.
3. Determinations of whether a Significant Financial Interest exists and whether a Significant Financial Interest constitutes an FCOI will be made based on the following:
   1. A Significant Financial Interest is related to Federally Funded Research when the COI Committee or the COI Committee Chair and Disclosure Office together reasonably determine that a Significant Financial Interest:
      1. Could be affected by the Federally Funded Research; or
      2. Is in an entity whose financial interest could be affected by the Federally Funded Research.
   2. An FCOI exists if the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the Federally Funded Research.
4. In cases where an FCOI is found and can be managed, a Management Plan will be developed in alignment with the COI/COC Policy and the Disclosure and Conflict Management Guidelines, subject to approval by the President.
5. In rare cases where an FCOI cannot be eliminated, reduced, or managed, the University Employee or GRA will be prohibited from engaging in the activity or Relationship.
6. When a Significant Financial Interest could impact the Federally Funded Research and is disclosed while the Research is ongoing, the University will review the Disclosure and determine whether a Significant Financial Interest and/or FCOI exists. Depending on the nature of the Significant Financial Interest, the University may put in place additional interim measures with regard to participation in the Federally Funded Research between the date of Disclosure and the completion of the review process.  These interim measures could include withholding funding until review and management can be assessed.
7. When required by the Funding Agency or when it is otherwise in the University's best interest, the University will complete a retrospective review of the University Employee’s or GRA’s activities and the Federally Funded Research, or portion thereof, conducted during the period of non-compliance, and determine whether or not there was bias in the design, conduct, or reporting of the Research.
8. In alignment with federal requirements and upon written request, the University will provide information to any requestor concerning disclosed Significant Financial Interests when the following criteria are met:
   1. The Significant Financial Interest was disclosed and still exists after the University’s review process has concluded;
   2. The University determined that the Significant Financial Interest is related to the Federally Funded Research; and
   3. The University determined that the Significant Financial Interest constitutes an FCOI.

1. The COI Official is designated as the University's institutional official with overall responsibility for the solicitation and review of Disclosures of Significant Financial Interests.
2. The COI Administrator is responsible for:
   1. Coordinating and facilitating the processes established to implement this Policy and coordinating such efforts with the University's Office of Research Administration (ORA), the Disclosure Office, and/or the COI Committee, as appropriate;
   2. Ensuring that all FCOI reports and other information are submitted to the Federal Funding Agencies, as required by the relevant Funding Agency regulations, policies, and/or laws; and
   3. Retaining all records related to Disclosures of financial interests; the review of and response to such Disclosures, whether or not a Disclosure resulted in the determination of a Financial Conflict of Interest; and all actions under this Policy or retrospective review(s), if applicable.
3. The COI Committee is responsible for making determinations regarding Significant Financial Interests, FCOIs, and Management Plans, as provided for in this Policy.
4. When the University carries out Federally Funded Research through a pass through recipient/subaward, the University, via the Office of Research Administration (ORA), must incorporate as part of a written agreement with the subawardee terms that flow down the Funding Agency requirements for FCOI. Subawardees can either apply their own policies and procedures to meet the requirements, or work with the University to utilize UMD’s.
5. The University Employee’s or GRA’s oversight official (e.g., Unit Head) is responsible for:
   1. Ensuring that steps set forth in the Management Plan are implemented;
   2. Taking reasonable steps to ensure the University Employee’s or GRA’s compliance with the Management Plan on an ongoing basis until the completion of the Federally Funded Research project; and
   3. Reporting to the COI Official or designee any non-compliance with the Management Plan.

1. Failure to comply with this Policy, the Disclosure and Conflict Management Guidelines, applicable University System of Maryland (USM) and University policies, and/or other Disclosure requirements associated with Sponsored Projects may be a violation of state and/or federal laws.
2. University Employees and/or GRAs found to be in violation of this Policy, the Disclosure and Conflict Management Guidelines, or state and/or federal laws based on any form of dishonesty or by acting in bad faith (including repeated violations), may face disciplinary action, as appropriate given the circumstances of the violation, the status of the University Employee or GRA, and in accordance with relevant University policies.
   1. Violations of this Policy include, but are not limited to, failure to submit a Disclosure; knowing submission of an incomplete, erroneous, or misleading Disclosure; knowing submission of a false certification; failure to comply with an approved Management Plan; and/or failure to comply with any other requirement of this Policy.
   2. Disciplinary actions may include, but are not limited to, restrictions on research activities at the University, freezing Federally Funded Research accounts, suspension and/or termination of employment, and/or expulsion from the graduate program, in accordance with USM and University policies or Graduate School policies.
   3. The Vice President for Research has the authority to implement disciplinary actions through existing mechanisms in collaboration with appropriate University Units.
3. The President may revoke approval of a Management Plan if a University Employee or GRA:
   1. Misrepresents the nature of an interest in an External Entity;
   2. Fails to comply with the Management Plan or any other conditions or restrictions; or
   3. If circumstances change, leading to an unmanageable FCOI, a violation of USM or University policy, and/or a conflict with applicable legal requirements.
4. If non-compliance with this Policy appears, in the reasonable judgement of the COI Official, to have biased the design, conduct, or reporting of Federally Funded Research, the COI Official shall be responsible for promptly notifying the Funding Agency of the corrective action taken or to be taken, as required by the relevant regulation, policy, or law.